Dexcom was made aware on 09/15/2016, that on (b)(6) 2016, the patient experienced a detached sensor wire.The sensor was inserted into the abdomen on (b)(6) 2016.The sensor failed to initiate as expected within period beyond 2 hours and sensor pod was removed.Upon removal, the patient's mother observed no sensor wire on the skin side of the sensor pod.The patient's mother brought the patient into the medical center's pediatric endocrinology due to discomfort during use of the continuous glucose monitoring (cgm) system.The patient had an x-ray during the same doctor's visit and the doctor found the sensor wire was detached at 1/4 f an inch within the patient's skin.The doctor requested for immediate, surgical removal.At the time of contact, the patient was stable but had a fever from an infection and was taking antibiotics.No product or data was returned for investigation.However, a copy of the pathology report was provided for evaluation.The reported event of detached sensor wire was confirmed.A root cause could not be determined.
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